← FDA Medical Device Classifications
Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs
QHC · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1075
Classification
- FDA Product Code
QHC- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 876.1075
- Review panel
- OB
- Medical specialty
- Gastroenterology, Urology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Obtain core soft tissue biopsy samples of internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown